RECRUITING
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Abbott Vascular Medical Device Registry
The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.
Conditions:
🦠 Acute Myocardial Infarction 🦠 Restenoses, Coronary 🦠 Coronary Artery Lesions 🦠 Venous Embolism 🦠 Arterial Embolism
🗓️ Study Start (Actual) 25 October 2020
🗓️ Primary Completion (Estimated) November 2030
✅ Study Completion (Estimated) November 2031
👥 Enrollment (Estimated) 3784
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Birmingham, Alabama, United States
📍 Little Rock, Arkansas, United States
📍 Los Angeles, California, United States
📍 Chicago, Illinois, United States
📍 Lincoln, Nebraska, United States
📍 Columbus, Ohio, United States
📍 Kingsport, Tennessee, United States
📍 Nedlands, WAUS, Australia
📍 Nedlands, WAUS, Australia
📍 Graz, Styria, Austria
📍 Aalst, Eflndrs, Belgium
📍 Dendermonde, Eflndrs, Belgium
📍 Xi'an, Shaanxi, China
📍 Jinhua, Zhejian, China
📍 Ningbo, Zhejian, China
📍 Chartres, Centre, France
📍 Paris, Ile, France
📍 Frankfurt, Hesse, Germany
📍 Mainz, Rhinela, Germany
📍 Leipzig, Saxony, Germany
📍 Bad Bevensen, Saxon, Germany
📍 Kiel, Schlesw, Germany
📍 Budapest, Hungary
📍 Milano, Lombard, Italy
📍 Milano, Lombard, Italy
📍 Nieuwegein, Utrecht, Netherlands
📍 Barcelona, Catalon, Spain
📍 Alicante, Valncia, Spain
📍 Madrid, Spain
📍 Aarau, Basel, Switzerland
📍 Bern, Switzerland
📍 Taichung, Mtaiwan, Taiwan
📍 Taipei City, Ntaiwan, Taiwan
📍 Tainan City, Staiwan, Taiwan
📍 Tainan City, Staiwan, Taiwan
📍 Sharjah, United Arab Emirates
More locations available...

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Subject is at least 18 years of age.
    • 2. Subject has a planned procedure, or underwent a procedure, that will use/used one or more Abbott target devices covered in this registry.
    • 3. Subject is willing and able to comply with, or has already completed, the follow-up schedule specified in this protocol.
    • 4. Subject must provide written informed consent prior to any clinical investigation-related data collection or be enrolled under an IRB/EC approved waiver of consent.

    Exclusion Criteria:

    • 1. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months of the date of procedure.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 23 September 2020
  • First Submitted that Met QC Criteria 30 September 2020
  • First Posted 5 October 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 June 2024
  • Last Update Posted 18 June 2024
  • Last Verified May 2024
I'm interested ...!!